The US government has reportedly approved AI-based memory loss prediction software for the first time. Darmiyan, a San Francisco-based brain imaging analytics company, says the FDA has granted De Novo approval for its product BrainSee. The software platform assigns “an objective score that predicts the likelihood of progression from aMCI to Alzheimer’s dementia within 5 years,” according to the medical company. Fierce Biotech first reported the announcement.

Darmiyan says BrainSee can predict memory loss progression using clinical brain MRIs and cognitive tests, which are already standard for patients worried about early signs of decline. After the program analyzes the imaging and cognitive assessments, it assigns a predictive score indicating the patient’s odds of memory deterioration within the following five years. At least in theory, that would lead to early treatment for some and peace of mind for others.

“This shifts the patient experience from prolonged anxiety to proactive management, which is crucial in an era of emerging Alzheimer’s treatments where accurate prognosis can help determine suitable treatment candidates,” Darmiyan wrote in a press release announcing the FDA approval. “The economic impact of BrainSee will be significant for all stakeholders in healthcare, promising to reduce the billions of dollars annually spent on Alzheimer’s care, through more effective management and treatment.”

The FDA’s “De Novo” designation means the product has no clear market predecessors but has proven its effectiveness and safety in clinical trials. BrainSee first received FDA “breakthrough” designation in 2021, an earlier stage of the approval path for a first-of-its-kind treatment. 

Darmiyan says BrainSee is fully automated and provides results on the same day the scans and cognitive test scores are entered. The company views the tech as shifting the treatment of mild / early cognitive decline from biomarker-based methods to “non-invasive and actionable forecasts of future improvement or progression.”

Japanese drugmaker Eisai and US-based Biogen have been working together on advancing research in the space of Alzheimer’s for nearly a decade. Finally, the FDA, granted the fruits of that labor, Leqembi, its blessing for intravenous use. This marks the first approved treatment that can slow the progression of Alzheimer’s.

Leqembi received a preliminary approval in January that allowed it to be used in a limited capacity. That approval was conditioned on the two drug makers conducting a confirmatory study to verify the drug's clinical benefit.

Though Leqembi slows Alzihmer’s progression, it is not a cure. Instead, it addresses the underlying biology that spurs Alzheimer's advancement. The drug works by reducing amyloid plaques, or "misfolded" proteins that form in the brain of a person with Alzheimer's.

Leqembi isn’t the only drug targeting beta-amyloid plaque buildup to treat Alzheimer's. Aduhelm received approval under the accelerated pathway in 2021, but it’s still not fully FDA-approved. But what sets Leqembi apart from its predecessor is that the drug demonstrated actual clinical benefit in addition to simply reducing the buildup of the AD-inducing proteins.

Besides needing a medical prescription, taking the drug will require professional administration in a hospital or infusion center every two weeks. The company, though it may not be its sole responsibility, recognizes its need to boost accessibility. In a public statement, Christopher Viehbacher, the CEO of Biogen, said the company’s main focus now is to work with Eisai to make Leqembi “accessible to eligible patients as soon as possible.”

The drug’s hefty price tag of $26,500 will unfortunately make it inaccessible to most. Current rules mean that it’s unlikely to be covered by Medicare. According to the Alzheimer's Association, those on Medicaid only should be able to get coverage of the FDA-approved drug in most cases. But, even if Medicaid does cover it, patients would be responsible for a 20 percent copay – or about $5,300. Experts predict the total cost of Leqembi treatment can run upward of $90,000 a year, if you take infusions and laboratory tests into account.

An expensive treatment program is something to consider for the one in nine Americans who are over the age of 65 that have Alzheimer’s dementia. That number is expected to grow as the nation’s aging population continues to grow. The number of Americans 65 and older is projected to climb from 58 million in 2021 to 88 million by 2050. This has led to an increased focus on treatments and diagnostics for Alzheimer’s, like blood tests that can detect the disease.

When doctors need to confirm an Alzheimer's diagnosis, they often turn to a combination of brain imaging and cell analysis. Both have their downsides. The latter involves a lumbar puncture, an invasive and painful procedure that’s more commonly known as a spinal tap. A doctor will insert a needle into the lower back to extract a sample of the patient’s cerebrospinal fluid. A lab technician then tests the sample for signs of progressive nerve cell loss and excessive amyloid and tau protein accumulation. MRI scans are less invasive but they’re often expensive and accessibility is an issue; not every community has access to the technology.

The next best tool for diagnosing Alzheimer’s disease is a blood test. While some can detect abnormal tau protein counts, they’re less effective at spotting the telltale signs of neurodegeneration. But that could soon change. This week, in the journal Brain, a multinational team made up of researchers from Sweden, Italy, the UK and US detailed a new antibody-based blood test they recently developed. The new test can detect brain-derived tau proteins, which are specific to Alzheimer’s disease. Following a study of 600 patients, the team found their test could reliably distinguish the illness from other neurodegenerative diseases.

Dr. Thomas Karikari, a professor of psychiatry at the University of Pittsburgh and one of the co-authors of the study, told The Guardian he hopes the breakthrough could help other researchers design better clinical trials for Alzheimer’s treatments. “A blood test is cheaper, safer and easier to administer, and it can improve clinical confidence in diagnosing Alzheimer’s and selecting participants for clinical trial and disease monitoring,” he said. There’s more work to be done before the test makes its way to your local hospital. To start, the team needs to validate that it works for a wide variety of patients, including those who come from different ethnic backgrounds.